Diseases of the oral cavity are numerous, and include periodontitis, gingivitis, dental caries, halitosis, aphthous ulcers and plaque formation. In many of these diseases, microorganisms have been implicated as causative agents. For example, periodontal diseases, including periodontitis and gingivitis, are caused by bacteria that form plaques on the surfaces of the teeth at the gingival sulcus or pocket. Bacteria known to provoke periodontitis include Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Bacteroides forsytus, and Treponema denticola. Current methods of treatment depend upon the severity of the disease. In almost all cases, regimens of treatment involving a medicated dentifrice and/or an oral rinse are utilized. Mild cases, such as simple calculus (tartar) buildup, are generally treated by the mechanical removal of the irritants. Interproximal cleaning is also important in maintaining gingival health. It is well known that mild cases of periodontal diseases in time progress to become more severe, and even pedantic cleaning with common dentifrices can only prolong the progression of these diseases. The large variety of toothpastes on the market is evidence to this immanent imperfection. More severe cases are generally treated surgically by the removal of gingival tissue, polishing of the tooth roots, or in some rare cases, splinting of the teeth. In the case of bacterial infection from one of the above-cited bacteria, treatment with both antibiotics and surgery becomes necessary. Most of these latter approaches are both painful and costly.
Prophylactic measures can be taken to forestall the occurrence, or recurrence of periodontal diseases. Known prophylactic measures include regular removal of calculus and plaque and the use of dental floss. Such measures are typically time consuming, and involve a strict regimen of care in order to be effective. For this reason, known prophylactic measures are rarely completely effective in preventing diseases such as periodontal disease.
Similarly, oral carcinomas are one of the most prevalent cancers worldwide. According to recent statistics, cancers of the oral cavity and oropharynx account for approximately 3% of all cancers diagnosed in the United States each year. The survival rate of oral carcinomas is about 50%, and deaths due to oral and oropharyngeal cancers make it one of the ten most common causes of death. The majority of oral cancers are squamous cell carcinomas and most involve the tongue, oropharynx, and floor of the mouth, with the lips, gingiva, dorsal tongue, and palate being less common sites.
Typically, surgery and/or radiation therapy are the current treatments of choice for oral cancers. Additionally, chemotherapeutic agents such as cisplatin, bleomycin, 5-FU, docetaxel, interferon alpha, and methotrexate may reduce tumor size and delay metastasis, but to date their use has not had significant positive effects. As a result, most current chemotherapeutic agents are used as adjuncts to standard surgery and/or radiation therapy, and more often in advanced stages of the disease.
Many and varied applications of dentifrice and mouthwash formulations have been described in the patent and medical literature for the use in oral hygiene and for the treatment of periodontal diseases. These formulations generally include a multitude of active ingredients such as fluoride agents, abrasives, and antibacterial agents. Illustrative of these are U.S. Pat. No. 5,374,418, U.S. Pat. No. 5,597,553, U.S. Pat. No. 6,086,372, U.S. Pat. No. 6,123,925, and U.S. Pat. No. 6,331,291.
U.S. Pat. No. 4,915,936 describes a dental hygiene oral rinse composition for the treatment of gingivitis and related periodontal diseases based on a calcium sulfate hemihydrate (beta-form) compound, water as a liquid carrier, alcohol, and other additives. The described formulation further incorporated a humectant to aid in the adherence of the calcium sulfate hemihydrate to teeth and tissue.
Similarly, several patents have suggested formulations for the topical treatment of carcinomas of the oral cavity. For instance, U.S. Pat. No. 5,626,838 describes the use of the NSAID agent ketorolac (5(benzoyl)-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid) for the treatment of primary squamous cell carcinoma, wherein the NSAID (non-steroidal anti-inflammatory drug) agent is in the form of a mouthwash, mouth spray, dental solution/rinse or toothpaste. However, none of these applications have been directed to a composition that would serve as both a prophylactic and a treatment for diseases of the oral cavity and oral carcinomas. Additionally, most of the current formulations described above utilize a variety of compounds that are potentially detrimental to the long-term health of the patients, especially children.
Thus, there exists a need for a dentifrice composition having both oral hygiene and oral carcinoma prophylactic properties, as well as having the ability to be used as a treatment for such maladies. Furthermore, such a dentifrice composition would utilize mostly natural ingredients in order to minimize any long term side effects. The present dentifrice compositions provide these features, and are composed with original, unparalleled components. They are easily prepared from non-toxic, pharmacologically pure materials, and have exhibited effects in the treatment of a variety of oral diseases and hygiene problems. Additionally, it appears that the use of the present dentifrice composition has prophylactic effects with regard to both diseases and carcinomas of the oral cavity.